NCT05794763

Brief Summary

This present study will compare the efficacy of in-person versus virtually-delivered Body Project groups. It will also evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint, negative affect, eating disorder symptoms, and the future onset of eating disorders over a 3-month follow-up in this population. It will also evaluate the effectiveness of this body acceptance class's ability to impact social appearance anxiety, body compassion, and self-stigma surrounding attaining help.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

March 20, 2023

Results QC Date

July 25, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

PreventionPeer LeaderFeeding and Eating Disorders

Outcome Measures

Primary Outcomes (2)

  • Change Over Time in Body Dissatisfaction

    Ten items from the Satisfaction and Dissatisfaction with Body Parts Scale assessed satisfaction with body parts with a response scale ranging from 1 = extremely dissatisfied to 6 = extremely satisfied. The mean score across the items is reported. Overall scores can range from 1 to 6 and a higher score indicate a greater level of body satisfaction.

    Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)

  • Change Over Time in Thin Ideal Internalization

    The eight-item Ideal-Body Stereotype Scale-Revised will assess endorsement of the thin beauty ideal using a response scale ranging from 1 = strongly disagree to 5 = strongly agree. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates a greater level of thin ideal internalization.

    Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)

Secondary Outcomes (9)

  • Change Over Time in Negative Affect

    Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)

  • Change Over Time in Dieting

    Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)

  • Body Comparison Orientation

    Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)

  • Change Over Time in Social Appearance Anxiety

    Pre intervention obtained on intake, and immediately post intervention.

  • Change Over Time in Body Compassion

    Pre intervention obtained on intake, and immediately post intervention.

  • +4 more secondary outcomes

Study Arms (2)

Body Project: In Person Delivery

EXPERIMENTAL

In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.

Behavioral: Peer Led Group Intervention

Body Project: Virtual Delivery

EXPERIMENTAL

In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.

Behavioral: Peer Led Group Intervention

Interventions

A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions

Also known as: Body Project
Body Project: In Person DeliveryBody Project: Virtual Delivery

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll gender identities besides cisgender and transgender men were eligible.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Cisgender and transgender men were excluded due to the fact that The Body Project is typically administered with groups of all cisgender women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Palo Alto, California, 94306, United States

Location

St. Mary's College of Maryland

Saint Marys City, Maryland, 20686, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Results Point of Contact

Title
Dr. Eric Stice
Organization
Stanford University

Study Officials

  • Eric Stice, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor at the 3-month follow-up is blind to participant randomization.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 3, 2023

Study Start

March 31, 2022

Primary Completion

March 5, 2024

Study Completion

March 5, 2024

Last Updated

December 16, 2024

Results First Posted

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations